ISO 13485:2016 was released in March 2016. All companies have 3 years in which to transition.
There are few industries where the importance of product conformity is as crucial as the design, manufacture, and testing of medical devices.
Manufacturers of any medical device must meet specific requirements for the safety and effectiveness of the medical products they sell.
The certification of a quality management system, specific for Medical Devices will be to your advantage. In many cases, it is a requirement for customers or organizations who manufacture medium and higher class medical devices and export their products to the global market such as Europe and Canada.
ISO 13485 is a stand-alone standard. The ISO 13485:2016 is based on ISO 9001:2008. It is intended to promote global alignment of appropriate regulatory requirements specific to quality/medical device quality systems for organizations.
Such organizations can be involved in one or more stages of the life-cycle. They include design and development, production, storage and distribution, installation, servicing of a medical device, and design and development or provision of associated activities (e.g. technical support). These requirements are critical for the medical device industry.
Who would want to be registered to ISO 13485?
- Organizations currently manufacturing private label medical devices, but are looking at eventually selling their product in the European Union.
- Organizations, such as consulting shops, which design, manufacture, and assemble medical and In Vitro diagnostic medical devices, and component manufacturers.
- Organizations that manufacture In Vitro Diagnostic Medical Devices that want to be prepared for any future regulatory requirements.
Are you an FDA Medical Device Manufacturing firm that is looking to improve your Quality System by adding ISO 13485 to your list of registrations/certifications?
Or are your customers requiring this additional registration/certification? We can help.
Our auditors have extensive hands on experience in the Medical Device industry. You will be working with ISO audit professionals.